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使用泼尼松龙或氢化可的松治疗肾上腺功能不全患者的死亡率风险:一项回顾性队列研究。

Mortality Risk in Patients With Adrenal Insufficiency Using Prednisolone or Hydrocortisone: A Retrospective Cohort Study.

机构信息

Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College, London, UK.

Faculty of Medicine and Public Health, HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand.

出版信息

J Clin Endocrinol Metab. 2021 Jul 13;106(8):2242-2251. doi: 10.1210/clinem/dgab347.

DOI:10.1210/clinem/dgab347
PMID:33993277
Abstract

CONTEXT

Prednisolone has been recommended rather than hydrocortisone for glucocorticoid replacement in adrenal insufficiency due its longer duration of action and lower cost.

OBJECTIVE

To determine mortality rates with prednisolone versus hydrocortisone.

METHODS

In this observational study, we used data extracted from a UK primary care database (Clinical Practice Research Datalink) to measure the relative mortality of patients with primary and secondary adrenal insufficiency, who were treated with either prednisolone or hydrocortisone, and control individuals who were individually matched for age, sex, period, and place of follow-up.

RESULTS

As expected, mortality in adrenal insufficiency irrespective of cause was increased, based on 5478 patients (4228 on hydrocortisone; 1250 on prednisolone) and 54 314 controls (41 934 and 12 380, respectively). Overall, the adjusted hazard ratio (HR) was similar with the 2 treatments (prednisolone, 1.76 [95% CI, 1.54-2.01] vs hydrocortisone 1.69 [1.57-1.82]; P = 0.65). This was also the case for secondary adrenal insufficiency. In primary disease (1405 on hydrocortisone vs 137 on prednisolone; 13 965 and 1347 controls, respectively), prednisolone users were older, more likely to have another autoimmune disease and malignancy, and less likely to have mineralocorticoid replacement. Nevertheless, after adjustment, the HR for prednisolone-treated patients remained higher than for those taking hydrocortisone (2.92 [2.19-3.91] vs 1.90 [1.66-2.16]; P = 0.0020).

CONCLUSION

In primary but not in secondary adrenal insufficiency, mortality was higher with prednisolone. The study was large, but the number of prednisolone-treated patients was small, and they had greater risk factors. Nonetheless, the increased mortality associated with prednisolone persisted despite statistical adjustment. Further evidence is needed regarding the long-term safety of prednisolone as routine replacement.

摘要

背景

由于作用持续时间更长且成本更低,在肾上腺功能不全的患者中,推荐使用泼尼松而非氢化可的松进行糖皮质激素替代治疗。

目的

确定泼尼松与氢化可的松治疗的患者死亡率。

方法

在这项观察性研究中,我们使用从英国初级保健数据库(临床实践研究数据链接)中提取的数据,来衡量原发性和继发性肾上腺功能不全患者使用泼尼松或氢化可的松治疗以及年龄、性别、随访时期和地点相匹配的个体对照者的相对死亡率。

结果

根据 5478 名患者(氢化可的松组 4228 名,泼尼松组 1250 名)和 54314 名对照者(氢化可的松组 41934 名,泼尼松组 12380 名)的数据,无论病因如何,肾上腺功能不全患者的死亡率均升高。总体而言,两种治疗方法的调整后危险比(HR)相似(泼尼松 1.76 [95%CI,1.54-2.01]与氢化可的松 1.69 [1.57-1.82];P=0.65)。继发性肾上腺功能不全也是如此。在原发性疾病中(氢化可的松组 1405 名,泼尼松组 137 名;氢化可的松组 13965 名,泼尼松组 1347 名对照者),泼尼松组患者年龄更大,更有可能患有另一种自身免疫性疾病和恶性肿瘤,且更不可能接受盐皮质激素替代治疗。尽管如此,调整后,泼尼松治疗患者的 HR 仍高于接受氢化可的松治疗的患者(2.92 [2.19-3.91]比 1.90 [1.66-2.16];P=0.0020)。

结论

在原发性而非继发性肾上腺功能不全中,泼尼松治疗的患者死亡率更高。该研究规模较大,但泼尼松治疗患者的数量较少,且存在更多的危险因素。尽管进行了统计学调整,但与泼尼松相关的死亡率增加仍然存在。需要进一步的证据来证明泼尼松作为常规替代治疗的长期安全性。

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